Associate Director, Clinical Operations - TMF

Piper Companies; Maryland; Hybrid; USD 130,000 - 155,000; Full time

Benefits offered by this job

Full benefits package

Job summary

Piper Companies is seeking an Associate Director, Clinical Operations - TMF to support a leading CRO, with remote work flexibility from the United States. The role focuses on leading TMF strategy, governance, and operational execution across multiple clinical trial programs, ensuring inspection readiness and regulatory compliance.

You will oversee TMF quality and governance, develop plans and SOPs, and supervise Clinical Operations Managers and TMF staff, acting as the primary TMF SME for

Qualifications

• Bachelor's degree in Life Sciences, Clinical Research, or related health field; advanced degree preferred.
• 10+ years of experience in pharmaceutical, biotechnology, CRO, or clinical research environments with increasing leadership responsibilities.
• 6+ years owning TMF strategy and managing TMF operations and teams.
• Expert knowledge of ICH-GCP, FDA regulations, DIA TMF Reference Model, TMF best practices, and inspection readiness.
• Hands-on experience developing TMF plans, SOPs, work instructions, and governance documentation.
• Proven experience supporting regulatory inspections, sponsor audits, and TMF remediation initiatives.
• Expertise with Veeva Vault TMF required; experience with additional eTMF systems preferred.
• Strong leadership, project management, communication, resource planning, and proposal development skills.
• Experience in infectious disease, HIV, oncology, medical device, government-funded research, or Phase I clinical trials is a plus.

Responsibilities

• Lead TMF strategy, governance, and operational execution across multiple clinical trial programs, ensuring inspection readiness at all times.
• Oversee TMF quality, completeness, accuracy, and timeliness in compliance with ICH-GCP, FDA regulations, and industry standards.
• Develop and maintain TMF plans, filing structures, SOPs, work instructions, and controlled documentation.
• Provide leadership and direct supervision to Clinical Operations Managers, TMF Specialists, and supporting clinical operations staff.
• Serve as the primary TMF subject matter expert for sponsors, executive leadership, audits, inspections, and regulatory interactions.
• Drive process improvement initiatives, risk mitigation strategies, CAPA activities, and TMF health metrics across the organization.
• Support proposal development, resource forecasting, budget planning, and cross-functional clinical operations initiatives.

Skills

Leadership

Project management

Communication

Resource planning

Proposal development

Regulatory compliance

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Tools

Veeva Vault TMF

eTMF systems

Job description

Associate Director, Clinical Operations - TMF

Piper Companies is seeking an Associate Director, Clinical Operations - TMF to support a leading clinical research organization managing government and commercial clinical trial programs across multiple therapeutic areas. This position is Remote.

Responsibilities for the Associate Director, Clinical Operations - TMF include:

• Lead TMF strategy, governance, and operational execution across multiple clinical trial programs, ensuring inspection readiness at all times.
• Oversee TMF quality, completeness, accuracy, and timeliness in compliance with ICH-GCP, FDA regulations, and industry standards.
• Develop and maintain TMF plans, filing structures, SOPs, work instructions, and controlled documentation.
• Provide leadership and direct supervision to Clinical Operations Managers, TMF Specialists, and supporting clinical operations staff.
• Serve as the primary TMF subject matter expert for sponsors, executive leadership, audits, inspections, and regulatory interactions.
• Drive process improvement initiatives, risk mitigation strategies, CAPA activities, and TMF health metrics across the organization.
• Support proposal development, resource forecasting, budget planning, and cross-functional clinical operations initiatives.

Required Qualifications for the Associate Director, Clinical Operations - TMF include:

• Bachelor's degree in Life Sciences, Clinical Research, or related health field; advanced degree preferred.
• 10+ years of experience in pharmaceutical, biotechnology, CRO, or clinical research environments with increasing leadership responsibilities.
• 6+ years of experience owning TMF strategy and managing TMF operations and teams.
• Expert knowledge of ICH-GCP, FDA regulations, DIA TMF Reference Model, TMF best practices, and inspection readiness requirements.
• Hands-on experience developing TMF plans, SOPs, work instructions, and governance documentation.
• Proven experience supporting regulatory inspections, sponsor audits, and TMF remediation initiatives.
• Expertise with Veeva Vault TMF required; experience with additional eTMF systems preferred.
• Strong leadership, project management, communication, resource planning, and proposal development skills.
• Experience in infectious disease, HIV, oncology, medical device, government-funded research, or Phase I clinical trials is a plus.

Compensation:

• Salary Range: $130,000-$155,000k
• Full Benefits Package: Provided during interview process

Keywords:

Associate Director Clinical Operations, Trial Master File, TMF, eTMF, Veeva Vault TMF, Clinical Operations, CRO, Clinical Research, FDA Regulations, ICH-GCP, DIA TMF Reference Model, Inspection Readiness, Sponsor Audits, Regulatory Compliance, TMF Governance, Quality Management, CAPA, SOP Development, Document Management, Clinical Trial Management, Oncology Clinical Trials, Infectious Disease Clinical Trials, HIV Research, Government Contracts, Clinical Project Management.